Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-25 have been canceled. Claim 46 has been added. Claims 26-46 are under consideration.
Applicant's arguments filed 2-25-26 have been fully considered but they are not persuasive.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Specification
The word “apoptosis” has been added to the sentence “SV40 large T antigen prevents cMyc-induced in murine fibroblasts” on pg 11, para 35, line 2, in the amendment filed 2-25-26.
Claim objections
It appears that the phrase “potency-determining factors” within the phrase “potency-determining factors OCT4 and SOX2 and SV40 T Antigen” in claim 26 applies to Oct4, Sox2, and SV40 T Antigen, so using the phrase “potency-determining factors” to describe Oct4 and Sox2 but not SV40 T antigen at the end of the claim does not make sense. It is unclear whether claim 26 is limited to cells comprising one or more non-episomal vectors encoding Oct4, Sox2, and SV40 T antigen or if they encompass cells comprising a) one or more non-episomal vectors encoding Oct4 and Sox2; and b) SV40 T antigen. Claim 26 can be written more simply as efficiently as ---An in vitro population of primate somatic cells comprising one or more non-viral episomal vectors encoding Oct4, Sox2, and SV40 T antigen, wherein the cells express the Oct4, Sox2, and SV40 T antigen---.
Claim 42 is objected to because it requires somatic cells containing a vector encoding Oct4, Sox2, and SV40 T antigen and that the cells “express the encoded Oct4 and Sox2”, but claim 42 does not require the cells express the SV40 T antigen. Nor does claim 42 require the cells express the optional coding sequences. Claim 42 can be written more simply as ---An in vitro population of primate somatic cells comprising one or more non-viral episomal vectors encoding Oct4, Sox2, and SV40 T antigen, and optionally Nanog, Klf4, cMyc, or Lin28, wherein the cells express the Oct4, Sox2, and SV40 T antigen, and optionally Nanog, Klf4, cMyc, or Lin28---.
Claim 46 is objected to because it requires exposing somatic cells to Oct4, Sox2, and SV40 T antigen and that the cells have a “higher potency level than the primary somatic cells”, but claim 46 does not require the cells contain a vector encoding Oct4, Sox2, and SV40 T antigen. Nor does claim 46 require the cells express the Oct4, Sox2, and SV40 T antigen. Nor does claim 46 require the cells are reprogrammed into pluripotent cells. Claim 46 can be written more simply as ---A method of reprogramming somatic cells into pluripotent cells, the method comprising: introducing a plasmid encoding Oct4, Sox2, and SV40 T antigen into isolated primate somatic cells such that pluripotent cells are obtained---.
Claim Rejections - 35 USC § 112
Written Description
Claims 26-45 remain and claim 46 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Withdrawn rejections
The rejection regarding a somatic cell comprising an episomal vector encoding, in order, a 1st promoter, Oct4, IRES2, Sox2, 2nd promoter, SV40 T antigen, IRES2, KLF4 in claim 33 has been withdrawn. Fig. 4 shows plasmid “pEP4EO2SET2K” which contains, in order, a 1st promoter, Oct4, IRES, Sox2, a 2nd promoter, SV40 T antigen, IRES, and KLF4.
The rejection regarding a somatic cell comprising an episomal vector encoding any Myc in claims 30, 31, 34, 35, 37, 39, 42 has been withdrawn because the claims have been limited to cMyc.
Pending rejections
A) The specification lacks written description for any isolated primate somatic cell comprising one or more non-viral episomal vectors encoding Oct4, Sox2, and SV40 T antigen as required in claims 26, 42, or 46 other than one plasmid encoding Oct4, Sox2, and SV40 T antigen. Fig. 2C described in examples 1-2 (pg 10-12) are self-inactivating lentiviral vectors encoding O2S+N2L+CMV+M2K+T (Fig. 2C, right panel, (pSIN4)-EF2 promoter-Oct4-IRES2-Sox2 (O2S - pg 11, 2nd to last line); pSIN4-EF2 promoter-Nanog-IRES2-Lin28 (N2L - pg 11, 2nd to last line); pSIN4-EF2 promoter-cMyc-IRES2-Klf4 (CMV-M2K - pg 11, line 7-8); and SV40 large T antigen (T – pg 11, para 35, line 6)). The pSIN4 vector is not non-viral as required in claim 26, 42, or 46.
Fig. 4 shows plasmid “pEP4EO2SET2K” which encodes Oct4, Sox2, and SV40 T antigen.
Table 2 (pg 16-17), items 8, 25, encode Oct4, Sox2, and SV40 T antigen.
Table 3 (pg 18-21), items described using “pEP4EO2SET2K” and “pEP4EO2SE-TERT2K” in Experiment 1, test #4 and #5; Experiment 3, “14T” & “19”, used “pEP4EO2SET2K”; Experiment 4, test #2, #4, #6, #8, #10, #12, #13 used “pEP4EO2SET2K”.
Fig. 5A and 5B (described on pg 5) show pEP4EO2S vectors encoding Oct4 and Sox2 but not SV40 T antigen.
The specification does not teach using more than one vector to encode Oct4, Sox2 and SV40 T antigen as broadly encompassed by claims 26, 42, 46.
Accordingly, the concept lacks written description.
Response to arguments
Applicants argue Fig. 5A and 5B show plasmids encoding Oct4 and Sox2. Applicants’ argument is not persuasive. The specification does not teach using more than one vector to encode Oct4, Sox2 and SV40 T antigen as broadly encompassed by claims 26, 42, 46.
B) The specification lacks written description for a somatic cell comprising one or more non-viral episomal vectors encoding Oct4 and Sox2 and SV40 T antigen, wherein the cell is “fetal or post-natal primate cells” as required in claim 27. Pg 4, para 11, says: “the primate pluripotent cells of the invention are substantially genetically identical to somatic cells from a fetal or post-natal individual. Fetal cells can be obtained from, e.g., amniotic fluid.” This is simply a comparison between pluripotent cells and somatic cells. The specification does not contemplate using somatic cells from a fetus or amniotic fluid for reprogramming. The specification teach transfecting somatic cells from a fetus or amniotic fluid with one or more non-viral episomal vector encoding Oct4 and Sox 2 and SV40 T antigen as encompassed by claims 26, 42, 46. The specification does not contemplate using “post-natal” somatic cells for reprogramming. The specification teach transfecting “post-natal” somatic cells with one or more non-viral episomal vector encoding Oct4 and Sox 2 and SV40 T antigen as encompassed by claims 26, 42, 46. Accordingly, the concept lacks written description.
Response to arguments
Applicants argue para 11 supports the claim. Applicants’ argument is not persuasive for reasons set forth above.
C) The specification lacks written description for a somatic cell comprising an episomal vector encoding, in order, a 1st promoter, Oct4, IRES2, Sox2, 2nd promoter, Myc, IRES2, KLF4, a 3rd promoter, NANOG, IRES2, LIN28 as required in claim 34. Claim 34 does not further limit claim 32 because claim 32 requires the vector encodes SV40 T antigen which is missing from claim 34. Fig. 4 and Tables 2 and 3 are described above. The specification does not disclose the vector of claim 34. Support has not been provided and none can be found. Accordingly, the concept lacks written description.
Response to argument
Applicants argue para 30 (pg 10) says the vector may contain “E-O2S” (promoter, Oct4, IRES, Sox2) and “C-M2K” (CMV promoter, cMyc, IRES, KLF4). Applicants’ argument is not persuasive because claim 34 does not further limit claim 32 which requires the vector encodes SV40 T-antigen. Claim 34 is missing the SV40 T-antigen coding region.
D) The specification lacks written description for a somatic cell comprising an episomal vector encoding, in order, a 1st promoter, Oct4, IRES2, Sox2, 2nd promoter, SV40 T antigen, IRES2, KLF4 and an episomal vector encoding, in order, a 1st promoter, Oct4, IRES2, Sox2, 2nd promoter, Myc, IRES2, KLF4, a 3rd promoter, NANOG, IRES2, LIN28 as required in claim 35. Pg 16, Table 2, shows vector #24 pEP4EO2SCM2LEN2L and vector #17 “pEP4EO2SET2K” which correlate to the vectors in claim 35. However, the specification does not contemplate transfecting somatic cells with both vectors. Accordingly, the concept lacks written description.
Response to argument
Applicants argue vectors #17 and #24 in Table 2 support the claim. Applicants’ argument is not persuasive because the specification does not contemplate transfecting somatic cells with both vectors.
E) The specification lacks written description for a somatic cell comprising an episomal vector encoding, in order, a 1st promoter, Oct4, IRES2, Sox2, 2nd promoter, SV40 T antigen, IRES2, KLF4, an episomal vector encoding, in order, a 3rd promoter, Oct4, IRES2, Sox2, 4th promoter, NANOG, IRES2, and KLF4, and an episomal vector encoding a 5th promoter, Myc, IRES2, KLF4, LIN28 as required in claim 37. Pg 16, Table 2, shows vector #17 “pEP4EO2SET2K”, #16 “pEP4EO2SEN2K” and #9 “pEP4EM2L” which correlate to the vectors in claim 35. However, the specification does not contemplate transfecting somatic cells with all three vectors. Accordingly, the concept lacks written description.
Response to argument
Applicants argue vectors #17, #16, and #9 in Table 2 support the claim. Applicants’ argument is not persuasive because the specification does not contemplate transfecting somatic cells with all three vectors.
F) The specification lacks written description for a somatic cell comprising an episomal vector encoding, in order, a 1st promoter, Oct4, IRES2, Sox2, 2nd promoter, NANOG, IRES2, LIN28, an episomal vector encoding, in order, a 3rd promoter, Oct4, IRES2, Sox2, 4th promoter, SV40 T antigen, IRES2, KLF4, and an episomal vector encoding a 5th promoter, OCT4, IRES2, Sox2, a 6th promoter, Myc, IRES2, KLF4 as required in claim 39. Pg 16, Table 2, shows vector #17 “pEP4EO2SET2K”, #18 “pEP4EO2SEN2L” and #13 “pEP4EEM2K” which correlate to the vectors in claim 35. However, the specification does not contemplate transfecting somatic cells with all three vectors. Accordingly, the concept lacks written description.
Response to argument
Applicants argue vectors #17, #18, and #13 in Table 2 support the claim. Applicants’ argument is not persuasive because the specification does not contemplate transfecting somatic cells with all three vectors.
New rejections
G) The specification lacks written description for exposing somatic cells to Oct4, Sox2, and SV40 T-antigen by any means as broadly encompassed by claim 46 other than introducing a plasmid encoding Oct4, Sox2, and SV40 T-antigen. The specification describes using lentiviral vectors or plasmids encoding Oct4, Sox2, and SV40 T-antigen (Example 1; Tables 2 and 3; Fig. 4 and 5). The specification does not teach administering lentiviral vectors encoding Oct4, Sox2, and SV40 T-antigen to somatic cells. The specification does not teach administering Oct4, Sox2, and SV40 T-antigen proteins to somatic cells as broadly encompassed by claim 46. Accordingly, claim 46 lacks written description other than somatic cells comprising plasmid encoding Oct4, Sox2, and SV40 T-antigen.
H) The specification lacks written description for obtaining any “reprogrammed cells having a higher potency level than the primary somatic cells” as required in claim 46. The phrase “the primary somatic cells” lacks antecedent basis. The claim encompasses obtaining any hair stem cell, retinal stem cell, liver stem cell, pancreatic stem cell, skin stem cell, etc. from any somatic cell using Oct4, Sox2, and SV40 T-antigen. However, the specification is limited transfecting somatic cells with a plasmid encoding Oct4, Sox2, and SV40 T-antigen such that pluripotent cells are obtained. The specification does not correlate obtaining pluripotent cells to obtaining any hair stem cell, retinal stem cell, liver stem cell, pancreatic stem cell, skin stem cell, etc. as broadly encompassed by claim 46. Accordingly, the concept lacks written description.
Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 26-46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 26 is indefinite. It appears that the phrase “potency-determining factors” within the phrase “potency-determining factors OCT4 and SOX2 and SV40 T Antigen” in claim 26 applies to Oct4, Sox2, and SV40 T Antigen, so using the phrase “potency-determining factors” to describe Oct4 and Sox2 but not SV40 T antigen at the end of the claim does not make sense. Because of that, it is unclear whether claims 26, 42, 46 are limited to cells comprising one or more non-episomal vectors encoding Oct4, Sox2, and SV40 T antigen or if they encompass cells comprising a) one or more non-episomal vectors encoding Oct4 and Sox2; and b) SV40 T antigen. Claim 26 can be written more simply as efficiently as ---An in vitro population of primate somatic cells comprising one or more non-viral episomal vectors encoding Oct4, Sox2, and SV40 T antigen, wherein the cells express the Oct4, Sox2, and SV40 T antigen---.
Claim 46 is objected to because it requires exposing somatic cells to Oct4, Sox2, and SV40 T antigen and that the cells have a “higher potency level than the primary somatic cells”. The phrase “the primary somatic cells” lacks antecedent basis. Claim 46 does not require the cells contain a vector encoding Oct4, Sox2, and SV40 T antigen. Nor does claim 46 require the cells express the Oct4, Sox2, and SV40 T antigen. Nor does claim 46 require the cells are reprogrammed into pluripotent cells. Claim 46 can be written more simply as ---A method of reprogramming somatic cells into pluripotent cells, the method comprising: introducing a plasmid encoding Oct4, Sox2, and SV40 T antigen into isolated primate somatic cells such that pluripotent cells are obtained---.
Claim Rejections - 35 USC § 103
A) Claims 26-28, 30, 32, 40-45 remain and claim 46 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mack (20100003757) in view of Hermeking (PNAS, 1994, Vol. 91, pg 10412-10416).
Mack transfected isolated primate somatic cells with a single plasmid encoding multiple reprogramming factors including Oct4 and Sox2 such that pluripotent cells were obtained (paragraphs 6; 17; 20; 23; 32; 141, lines 1-7; 159, lines 1-6 and lines 11-13; para 225). The cells were differentiated into various somatic cells (para 209-210). The plasmid of Mack (para 228; “Use of a residue-free reprogramming plasmid”) are episomal as encompassed by claim 26 and 42 because applicants taught plasmids were unstable episomal vectors that cannot replicate their DNA (paragraph 27).
Mack did not teach the cells comprised SV40 T antigen as required in claims 26 and 42.
However, Hermeking taught SV40 T antigen prevented cMyc-induced apoptosis (abstract) and Hanna taught SV40 T antigen enhanced reprogramming efficiency (abstract).
Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make isolated primary somatic cells comprising a non-viral episomal vector encoding Oct4 and Sox2 as described by Mack and add a vector encoding SV40 T antigen as described by Hermeking and Hanna. Those of ordinary skill in the art at the time of filing would have been motivated to do so to prevent cMyc-induced apoptosis as described by Hermeking or improve reprogramming as described by Hanna.
The limitation cells “obtained from fetal or post-natal primate individuals” as required in claim 27 is a product-by-process limitation buried in a method claim. The claim does not clearly set forth an active step of isolating fetal or post-natal cells or an active step of fetal or post-natal cells; therefore, the steps do not have to occur. All cells are ultimately obtained from a fetal or post-natal primate because adult cells are derived from fetal or post-natal cells. Therefore, the concept of cells “obtained from fetal or post-natal primate individuals” in claim 27 encompasses any cell because all cells are ultimately derived from fetal or post-natal cells. In other words, the phrase “obtained from fetal or post-natal primate individuals” bears no patentable weight because it does not distinguish the cells of Mack (ultimately obtained from fetal or post-natal cells) from those claimed.
Mack taught the pluripotent cells were human as required in claim 28.
Mack taught the pluripotent cells in culture media as required in claims 40, 42, and 44.
Culturing the cells 18 days as required in claims 41 and 45 was obvious in view of Mack who taught culturing for 14 days. Those of ordinary skill in the art at the time of filing would have been motivated to extend culture to 18 days to obtain more cells.
The cells must “transiently express SV40 T antigen” as required in claim 43 because a plasmid was used to express SV40 T antigen.
Claim 46 has been included for reasons set forth above regarding claim 26 and 42.
Response to arguments
Applicants argue the rejection fails to provide a reasonable argument to combine the references. Applicants’ argument is not persuasive. A motivational statement has been provided.
Applicants argue claim 26 and 42 do not require cMyc. Applicants’ argument is not persuasive. Claims 26 and 42 encompass using cMyc (see claims 30, 31, 34, 35, 37, 39).
B) Claims 29, 31 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mack (20100003757) in view of Hermeking (PNAS, 1994, Vol. 91, pg 10412-10416) as applied to claims 26-28, 30, 32, 40-46 and further in view of Takahashi (Cell, 2007, Vol. 131, pg 861-872), and Yu (Science, 2007, Vol. 318, pg 1917-1920).
The combined teachings of Mack and Hermeking taught transfecting isolated primate somatic cells with a single plasmid encoding multiple reprogramming factors including Oct4, Sox2, SV40 T-antigen and optionally Lin28, Nanog, Myc, KLf4 such that pluripotent cells were obtained.
The combined teachings of Mack and Hermeking did not teach Oct4 and Sox2 and Lin28, Nanog, Myc, or Klf4 were human as required in claims 29 and 31.
However, Yu used cDNA encoding human Oct4, Sox2, Nanog and Lin28 (pg 3, “Lentiviral transduction…” in the Supplementary information), and Takahashi (2007) used human Oct4, Sox2, Klf4 and cMyc (pg 869, col. 2, plasmid construction).
Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to transfect somatic cells with a plasmid encoding Oct4 and Sox2 as described by Mack using human Oct4 and Sox2 as described by Takahashi and Yu. Those of ordinary skill in the art at the time of filing would have been motivated to use human Oct4 and Sox2 because the cells are also humans.
Response to arguments
Applicants argue the rejection must be dropped because rejection A) is faulty. Applicants’ argument is not persuasive for reasons set forth above.
C) Claims 33-39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mack (20100003757) in view of Hermeking (PNAS, 1994, Vol. 91, pg 10412-10416) as applied to claims 26-28, 30, 32, 40-46 and further in view of Takahashi (Cell, 2006, Vol. 126, pg 663-676), Takahashi (Cell, 2007, Vol. 131, pg 861-872), and Yu (Science, 2007, Vol. 318, pg 1917-1920).
The combined teachings of Mack and Hermeking taught transfecting isolated primate somatic cells with a single plasmid encoding multiple reprogramming factors including Oct4, Sox2, SV40 T-antigen and optionally Lin28, Nanog, Myc, KLf4 such that pluripotent cells were obtained.
The combined teachings of Mack and Hermeking did not teach the vector components in the order as written in claims 33-39.
However, all of the components were described by the combined teachings of Mack, Hermeking, Yu, Takahashi (2006), and Takahashi (2007). The order in which they are set forth in claims 33, 34, 35, 37, 39 was simply a matter of design choice because the order was variable as shown by Mack, Yu, Takahashi (2006), and Takahashi (2007). Those of ordinary skill in the art at the time of filing would have been motivated to arrive at the claimed structures to functionally express the desired proteins in a reasonable number of vectors.
Claims 36 and 38 require the promoter is an EF1α or CMV promoter which is taught by Mack (para 50, 224; Fig. 4).
Response to arguments
Applicants argue the rejection must be dropped because rejection A) is faulty. Applicants’ argument is not persuasive for reasons set forth above.
Double Patenting
The rejection of claims 21-25 on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10106772, 9499786, 8440461, and 8183038 has been withdrawn.
The claims of 10106772 are drawn to:
A method of reprogramming human somatic cells, the method comprising the steps of:
introducing a non-integrating vector encoding Oct-4 and Sox2 and at least one of Nanog and Lin28 operably linked to one or more heterologous promoters into isolated human somatic cells; and culturing the somatic cells under embryonic stem (ES) cell culture conditions such that pluripotent reprogrammed cells are obtained.
The claims of 9499786 are drawn to:
1. An enriched population of human pluripotent cells having a normal karyotype, wherein the human pluripotent cells comprise the genome of a single somatic cell of a postnatal individual human and further comprise an integrated non-native polynucleotide sequence encoding potency-determining factors comprising Oct-4 and Sox2.
2. The population of claim 1, wherein the potency-determining factors additionally comprise at least one of Nanog or Lin28.
The claims of 8440461 drawn to:
A method of reprogramming primate somatic cells, the method comprising the steps of: introducing a retroviral vector encoding a plurality of potency-determining factors into the primate somatic cells under conditions sufficient to reprogram the cells, wherein the potency-determining factors comprise Oct-4 and Sox2, and do not comprise c-Myc and Klf4; and culturing the primate somatic cells under embryonic stem cell culture conditions to obtain pluripotent reprogrammed cells. (Claim 1 of Parent application 12/053440 now US patent 8440461)
Claim 1 of 8183038 is drawn to:
1. A composition comprising recombinant nucleic acid encoding potency-determining factors SOX2, OCT-4, NANOG, and LIN28, the factor-encoding nucleic acid being operably linked to at least one heterologous promoter, wherein the composition induces reprogramming when introduced into a mammalian cell.
10106772, 9499786, 8440461, and 8183038 did not teach somatic cells containing a non-viral episomal vector encoding Oct4 and Sox2 and SV40 T antigen as required in claims 26, 44, 46.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638